Australia, Sweden Issue Heparin Recalls, UK Issues Alert

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ePT--the Electronic Newsletter of Pharmaceutical Technology

Problems associated with contamination of heparin products continue after worldwide recalls in March in the United States, Italy, France, and Denmark.

Australia, Sweden, and United Kingdom (Apr. 22)-Problems associated with contaminated heparin products continue after worldwide recalls in March in the United States, Italy, France, and Denmark.

Australia. The Therapeutic Good Administration (TGA), Australia’s medicines regulator, has recalled five batches of “Clexane,” (enoxaparin) a heparin-containing anticoagulant from Sanofi Aventis (Paris). The recall is attributed to the detection of an impurity in the batches.

Since March 2008, TGA has required testing of all heparin-containing products in Australia as a result of the finding of over-sulfated chondroitin in heparin products in the United States and Europe. TGA has not received any reports of adverse events associated with Clexane.

The affected batches are: Clexane 20 mg (batch 02115); Clexane 40 mg (batch 04526); Clexane 80 mg (batch 08009); and Clexane 100 mg (batches 01007 and 01011). TGA has stated plans to acquire alternative batches of heparin but fears that the worldwide problems of heparin contamination may result in a supply shortage.

Sweden. The Swedish Medical Products Agency (MPA) has recalled batches of Clexane  (marketed as “Klexane” in that country). Following the recall of Baxter’s heparin products, the agency required all companies supplying heparin to test their products for specific contamination. According to the agency, “A few batches of the low molecular mass heparin Klexane were found to be contaminated with low levels of the same impurity as in the unfractionated heparin detected in the US, i.e., oversulfated chondroitin sulfate(OSCS). Therefore, the Medical Products Agency decided to recall these contaminated batches simply as a precautionary measure.” MPA reports it has not received reports of severe adverse reactions, and batches of Klexane that have not been withdrawn do not contain the impurity.

United Kingdom. UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released a letter to healthcare professionals stating that “some” batches of Clexane prefilled syringes have been distributed with “low levels” of OSCS within 4–6 weeks. The letter emphasizes that no evidence of adverse reactions attributed to these products has been reported. The agency states it has “no similar concerns with other heparin products in the UK but continue[s] to keep the situation under close review.” Although no recall was issued, MHRA expects to receive new and uncontaminated stock of Clexane in June 2008.

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